Tradeh...You are correct. A similar thought hit me as I was studying a piece posted by penny double which described how a NEW FDA process was going to function. I had flashbacks when I read it. This is how (any) technical/regulatory/business interface process works. This kind of process has not changed in 100 years except to add more details/facts/quicker and more accurately, which sounds good but in fact it adds complexity, etc, etc. IMO, the whole lab rat/invitro trials thing is in the way.
If somehow we could recognize that this crisis (CNS diseases) is killing us and it is getting worse. Our methods need to be changed to at LEAST reflect to scope of this issue. This is not a freaking GAME here. The resources being expended do not reflect the severity of the issues.
I also concluded (maybe in error) that the REAL function of the FDA in this context has been to write enough rules and processes to keep decision processes focused on being SAFE and EFFECTIVE (not fast). BP likes this in a way b/c it functions to limit their legal exposure..."Hey, we are FDA approved"...do not blame us. In the meantime kids/adults w/CNS issues are not getting treated but the FDA and BP all have their jobs still. In other words, this process is not working to solve THE PROBLEM of CNS diseases. Just telling patients they are UNTREATABLE is not good enough.
So, it always ends up being a money discussion. BP is the only group with enough $$$ to even do testing/trials according to historical conventions and protocols. (BUT, why should they if it hurts them?) The FDA has no money and sees itself as the safety gatekeeper. Who advocates for the individual patients? If the central government were not so corrupt and incompetent it could help. This needs to be fixed in the private sector. IMO, Gottlieb, Dr. M and others could probably figure out a good/low risk faster way out of the swamp but not by using conventional methods. Unless a massive amt. of money is thrown in the pot we will probably stay where we are. My hope is that A2-73 starts us down the better, shorter path but unless there is proper incentive it will take a very long time to offset the drag of the existing system.
